Head and Neck CancerPhase 4MICR-ORLNCT06807034
Impact of the Oral Microbiota on Relapse in HNSCC Patients
A Phase 4 study testing buccal swabs in people with Head and Neck Cancer, run by Institut Sainte Catherine at 1 site in France.
Trial summary
to characterise the impact of microbiota in radiotherapy efficacy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- buccal swabs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 18 Nov 2024to 20 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- head and neck cancer
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
to characterise the impact of microbiota in radiotherapy efficacy
- Conditions
- Head and Neck Cancer
- Being tested
- buccal swabs
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
buccal swabsOther
buccal swabs for microbiota analysis before and after radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| buccal swabs | Experimental | buccal swabs for microbiota analysis before and after treatment Receives: Other: buccal swabs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota
Analysis of buccal microbiota by 16SrRNA gene sequencing
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start18 Nov 2024
- Primary completion20 Jan 2026 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Sainte Catherine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807034
- Sponsor's protocol ID
- MICR-ORL
- Acronym
- MICR-ORL
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Oral Microbiota on Relapse in HNSCC Patients
- ClinicalTrials.gov ID
- NCT06807034
- Acronym / sponsor ID
- MICR-ORL / MICR-ORL
- Conditions
- Head and Neck Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institut Sainte CatherineUniversity, hospital or other
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 20 Jan 2026 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
to characterise the impact of microbiota in radiotherapy efficacy
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| buccal swabs | Experimental | Other: buccal swabsbuccal swabs for microbiota analysis before and after treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- head and neck cancer
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| buccal swabsbuccal swabs for microbiota analysis before and after radiotherapy | Other | buccal swabs |
Primary outcome
Microbiota
Time frame: 2 years
Analysis of buccal microbiota by 16SrRNA gene sequencing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing buccal swabs in people with Head and Neck Cancer, run by Institut Sainte Catherine at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.